ComplianceOnline

Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing.

This 2-day seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE. Specifically, this seminar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. In addition to potency methods this seminar addresses immunogenicity methods for preclinical and clinical studies. The format of the seminar offers an examination of current best practices as well as time to dissect examples of documentation with emphasis on beneficial systems to consider. Scientists who attend this 2-day seminar will gain knowledge that will be beneficial in helping to achieve well-controlled validated methods.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

  • Understanding the different requirements for small versus large molecules
  • Mapping appropriate timelines with decision points
  • Designing, developing, optimizing, and validating key methods
  • Potency methods, other release and stability methods
  • Preclinical and clinical methods
  • Use of DOE and statistical analysis
  • Handling of critical materials
  • Process monitoring concepts
  • Assessment of orthogonal methods
  • Assessing readiness for validation
  • Defining the validation protocol with real-time capture of data analysis
  • Maintaining quality through documentation

Who will Benefit:

Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar:

  • Validation Scientists
  • QA/QC
  • Regulatory Affairs
  • Laboratory Managers
  • Assay Development Specialists
  • Statistician
  • CMC Titles
  • Bio Assay
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • Overview of Biologics and Biotechnology
  • Differences between small molecule and large molecule therapeutics
  • Assays required for biologics
  • Timelines
  • Regulatory guidances
  • GxP in biologics
  • Analytical CMC methods and bioassays
  • Assays supporting product development, release, and stability
  • Portfolio of required assays
  • Mechanism of action and potency methods
  • Selection of potency-indicating method(s)
  • Assay formats/platforms
  • Consideration of reagents, endpoints, signal to background
  • Standardizing cell culture procedures
  • Understanding and managing assay variability
  • Overview of feasibility to validation
  • Early development - feasibility
  • Use of DOE
  • Involvement of statisticians
  • Development and final development
  • Optimizing the assays
  • Validation of cell-based methods
Day 02(8:30 AM - 4:30 PM)
  • Assays supporting preclinical and clinical studies
  • Regulatory guidance
  • Assay platforms
  • Reagents, endpoints, signal to background
  • Method development
  • Assessing matrix effects
  • Method optimization
  • Validation parameters
  • Incurred sample reanalysis
  • Immunogenicity methods
  • Screening methods
  • Confirmatory methods
  • Neutralizing antibody method
  • Biomarker validation
  • Written procedures (methods, protocols, SOPs)
  • Analyst training
  • Maintaining quality in-house and in outsourcing
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Gwen Wise-Blackman

Gwen Wise-Blackman
Principal Consultant, Gwen Wise-Blackman Consulting, LLC

Gwen Wise-Blackman, Ph.D., has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. She is currently Principal Consultant at Gwen Wise-Blackman Consulting. Her career focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,699.00

Seminar One Registration

June 21-22, 2018, San Francisco, CA

$7,799.00
$10,194.00 (23%)*

Save $2,395.00

Special Group Discount Register for Six attendees

June 21-22, 2018, San Francisco, CA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Online using Credit card

    $1,699.00

    Seminar One Registration

    October 25-26, 2018, Chicago, IL




    The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.


    For discounts on multiple registrations, contact customer care at +1-888-717-2436.

    Other Registration Option

    By order form / PO#

    Payment Mode

    By Check -
    Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

    ComplianceOnline (MetricStream, Inc),
    2479 East Bayshore Road Suite 260
    Palo Alto, CA 94303
    USA

    By Wire -

    Register / Pay by Wire Transfer

    Please contact us at +1-888-717-2436 to get details of wire transfer option.

    Terms & Conditions to Register for the Seminar/Conference/Event

    Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

    Payment:
    Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

    Cancellations and substitutions:
    Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

    On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

    Substitutions may be made at any time. No-shows will be charged the full amount.

    We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

    In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

    Attendance confirmation and documents to carry to the seminar venue:
    After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

    Conference photograph / video:
    By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

    Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • 1

    San Francisco, CA
    June 21-22, 2018

    Hotel

    DoubleTree by Hilton San Francisco Airport
    835 Airport Blvd,
    Burlingame, CA, 94010-9949, USA

    Tel: +1 650-344-5500

    How to Reach

    General Driving Directions:

    Directions from San Francisco International Airport, CA: 4.8 mi.
    • Depart from San Francisco International Airport, CA
    • Take ramp left for US-101 South toward San Jose (2.5 mi.)
    • At exit 419B, take ramp right and follow signs for Broadway (0.2 mi.)
    • Turn left onto Broadway (0.2 mi.)
    • Turn right onto Old Bayshore Hwy / Bayshore Hwy (0.1 mi.)
    • Turn left onto Airport Blvd (0.7 mi.)
    • Arrive at Airport Blvd on the right (0.0 mi.)
    Directions from San Jose International Airport, CA: 31.1 mi.
    • Depart Airport Blvd toward Airport Blvd (1.0 mi.)
    • Bear left toward Skyport Dr (0.3 mi.)
    • Keep straight onto Skyport Dr (0.1 mi.)
    • Take ramp left for CA-87 N / Guadalupe Pkwy (0.7 mi.)
    • At exit 9B, take ramp left for US-101 North toward San Francisco (28.6 mi.)
    • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
    • Keep straight onto Anza Blvd (0.2 mi.)
    • Turn right onto Airport Blvd (0.0 mi.)
    • Arrive at Airport Blvd on the right (0.0 mi.)
    Directions from Metropolitan Oakland International: 27.5 mi.
    • Depart Airport Dr toward Airport Dr (0.3 mi.)
    • Turn right onto Alan Shepard Way (0.0 mi.)
    • Turn right onto John Glenn Dr (0.5 mi.)
    • Turn right onto Ron Cowan Pkwy (0.0 mi.)
    • Take ramp left for Airport Dr (0.7 mi.)
    • Turn right onto CA-61 / Doolittle Dr (0.9 mi.)
    • Keep left to stay on CA-61 / CA-112 / Davis St (0.5 mi.)
    • Take ramp right for I-880 South toward San Jose (6.7 mi.)
    • At exit 27, take ramp right for CA-92 West toward San Mateo Br (13.1 mi.)
    • At exit 13B, take ramp right for US-101 toward San Jose / San Francisco (4.1 mi.)
    • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
    • Keep straight onto Anza Blvd (0.2 mi.)
    • Turn right onto Airport Blvd (0.0 mi.)
    • Arrive at Airport Blvd on the right (0.0 mi.)

    Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

    2

    Chicago, IL
    October 25-26, 2018
    (Venue to be announced shortly)

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

    Media Partner:

    Media Partner

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Local Attractions of San Francisco, CA

    Think Escape Party Bus

    Think Escape Party Bus
    San Francisco Bay Area

    Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

    Alcatraz Lunch Cruise

    Alcatraz Lunch Cruise

    The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

    Luxury Catamaran Sailing Cruise

    Luxury Catamaran Sailing Cruise

    A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

    City Kayak

    City Kayak

    City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

    Think Escape Casino

    Think Escape Casino Tour
    San Francisco Bay Area

    San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity

    Local Attractions of Chicago, IL

    Windy

    Windy

    One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.

    Adler Planetarium and Astronomy Museum

    Adler Planetarium and Astronomy Museum

    The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
    Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!

    Arlington International Racecourse

    Arlington International Racecourse

    With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.

    Art Institute of Chicago

    Art Institute of Chicago

    You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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